FDA Recall D-0623-2024

FDC Limited · Aurangabad, Maharashtra State, N/A

Class II Ongoing 660 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India.

Lot / code: Lot#: a) 084C040, Exp 02/28/2026; b) 084A024, Exp12/31/2025.

Quantity: 66,528 bottles

Reason for recall

Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

Recall record

Recall number: D-0623-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S. A. Nationwide
Recall initiated: 2024-07-23
Classified by FDA Center: 2024-08-01
FDA published: 2024-08-07
Recalling firm: FDC Limited
Firm location: Aurangabad, Maharashtra State, N/A, India

Drug identification

Brand name(s): CIPROFLOXACIN
Generic name(s): CIPROFLOXACIN
Manufacturer(s): Leading Pharma, LLC
NDC(s): 69315-308
Route(s): OPHTHALMIC

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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